Opioid Treatment Programs

PURPOSE: This rule describes the specific functions, policies, and practices required for certified opioid treatment programs. PUBLISHER’S NOTE: The secretary of state has determined that publication of the entire text of the material that is incorporated by reference as a portion of this rule would be unduly cumbersome or expensive. This material as incorporated by reference in this rule shall be maintained by the agency at its headquarters and shall be made available to the public for inspection and copying at no more than the actual cost of reproduction. This note applies only to the reference material. The entire text of the rule is printed here. (1) Certification Requirements. To be certified as an opioid treatment program (OTP) by the department, the program must comply with the following prior to delivering services: (A) The program shall comply with applicable federal, state, and local laws and regulations, including those under the jurisdiction of the U.S. Drug Enforcement Administration (DEA); Department of Health and Human Services, Substance Abuse and Mental Health Services Administration (HHS/SAMHSA); and the Department of Health and Senior Services, Bureau of Narcotics and Dangerous Drugs (DHSS/BNDD); (B) The program shall comply with 9 CSR 10-5 General Program Procedures, 9 CSR 10-7 Core Rules for Psychiatric and Substance Use Disorder Treatment Programs, and 9 CSR 30-3 Substance Use Disorder Prevention and Treatment Programs, as applicable; and (C) The program shall have appropriate accreditation from CARF International (CARF), The Joint Commission (TJC), Council on Accreditation (COA), or other accrediting body approved by the department for the services described in the regulation. National accreditation or recognition as an OTP or accreditation or recognition as an OTP in a state other than Missouri is not equivalent to certification as an OTP by the department. (2) Medication Administration, Dispensing, and Use. OTPs shall only utilize medications for opioid use disorder (MOUD) that are approved by the Food and Drug Administration under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) for use in the treatment of opioid use disorder (OUD). (A) Opioid agonist, partial agonist, and antagonist treatment medications shall be administered and dispensed by a practitioner licensed in Missouri and registered under the appropriate state and federal laws to administer or dispense opioid drugs. (B) Written policies and procedures shall be maintained to ensure the following dosage form and initial dosing requirements are met: 1. Methadone is prescribed by a qualified prescriber, administered and dispensed only in oral form, and formulated in a manner to reduce its potential for parenteral abuse; and 2. For each new individual enrolled in an OTP, the initial dose of methadone shall be individually determined and shall include consideration of the type(s) of opioid(s) involved in the individuals opioid use disorder, other medications or substances being taken, medical history, and severity of opioid withdrawal. (C) The total dose for the first day shall not exceed fifty (50) milligrams unless the OTP practitioner, licensed under Missouri law and registered under the appropriate Missouri and federal laws to administer or dispense MOUD, finds sufficient medical rationale, including but not limited to if the individual is transferring from another OTP on a higher dose that has been verified, and documents in the individual’s record that a higher dose was clinically indicated. 1. Each opioid agonist medication is administered and dispensed in accordance with its approved product labeling. Dosing and administration decisions shall be made by a qualified prescriber familiar with the most up-to-date product labeling. These procedures must ensure any significant deviations from the approved labeling, including deviations with regard to dose, frequency, or the conditions of use described in the approved labeling, are specifically documented in the individual record. (D) If a prescription drug monitoring program (PDMP) is available, the program physician and other staff, as permitted, shall register and utilize the PDMP in accordance with federal, state, and local regulations. Policies and procedures shall be maintained regarding use of the PDMP information for diversion control planning. (E) Individuals admitted to an OTP may be provided with naloxone or, if insured, a prescription for naloxone. (3) Program Administration. The OTP shall have a program sponsor and a medical director. (A) The program sponsor shall be responsible for the general establishment, certification, accreditation, and operation of the program, ensuring it is in continuous compliance with all federal, state, and local laws and regulations related to the use of opioid agonist and partial agonist treatment medications in the treatment of opioid use disorder. (B) The medical director shall be a physician licensed in Missouri and is responsible for overseeing all medical services and behavioral health services provided by the OTP, performing them directly or by delegating specific responsibilities to an authorized program physician and healthcare professionals functioning under their direct supervision. The medical director shall ensure all medical, psychiatric, nursing, pharmacy, toxicology, and other services offered by the OTP are conducted in compliance with federal, state, and local regulations at all times. Other responsibilities of the medical director include, but are not limited to— 1. Ensuring individuals meet admission criteria and receive the required physical examination(s) and laboratory testing; 2. Prescribing methadone and other FDA-approved medications with the individual’s input, ensuring the prescribed dosage of medication is appropriate to their needs; 3. Reviewing each individual’s initial treatment plan and reviewing and updating the plan based on their needs; and 4. Coordinating care and consulting with each individual’s treatment team on a regular basis. (4) Service Delivery Requirements. A range of treatment and rehabilitation services shall be provided to address the therapeutic needs of individuals served. The combination and frequency of services shall be tailored to each individual based on an individualized assessment and treatment plan that was created after shared decision-making between the individual served and the clinical team. All medications approved by the FDA for treatment of OUD shall be available to meet individual needs. (A) At a minimum, the following services as defined in 9 CSR 30-3.110 or as specified in another regulation, must be available to all individuals based on needs and treatment goals: 1. Comprehensive assessment; 2. Communicable disease counseling; 3. Community support; 4. Transfer, transition, and discharge planning; 5. Crisis prevention and intervention; 6. Drug testing; 7. Employment/education services; 8. Family conference; 9. Family therapy; 10. Group counseling, including trauma and co-occurring disorders; 11. Group rehabilitative support; 12. Individual counseling, including trauma and cooccurring disorders; 13. Medication services; 14. Medication services support; and 15. Medical evaluations, as specified in this rule. (B) The services must be available at the OTP’s primary location or through a documented agreement with another qualified service provider. Services shall be offered at least six (6) days per week. Medical and psychosocial services shall be available during the early morning and/or evening to ensure individuals have access to services. (C) All medical services shall be offered and occur simultaneously with clinical therapy, education, development of positive social supports, and ongoing treatment and rehabilitation for substance use disorders and related life issues. (D) OTPs shall directly provide, or make available through referral to adequate and reasonably accessible community resources, other support services including, but not limited to, rehabilitation, education, and employment for individuals who request such services or have been determined by program staff to be in need of these services. (E) Information and education shall be provided in areas such as community resources and behavioral health disorders. (F) Services may be provided via telehealth to enhance accessibility for individuals served. (5) Admission Criteria. Individuals shall meet diagnostic criteria for active moderate to severe OUD, OUD remission, or high risk for recurrence or overdose. (A) The program physician shall ensure each individual voluntarily chooses treatment with MOUD, all relevant facts concerning the use of the MOUD are clearly and adequately explained, and each individual provides informed consent to treatment. (B) Documentation in the individual record must indicate clinical signs and symptoms of opioid use disorder. (C) Decisions regarding the most appropriate medication shall be individualized, based on personal needs and goals, throughout the individual’s engagement in treatment. (6) Admission for Priority Populations. OTPs that have a contract with the department shall ensure priority admission for— (A) Women who are pregnant and use intravenous drugs; (B) Women who are pregnant or postpartum, up to one (1) year after delivery; (C) Individuals who use intravenous drugs; (D) Women who have children and are at risk of losing custody or are attempting to regain custody; (E) Individuals who test positive for the human immunodeficiency virus (HIV); (F) Individuals determined to be high risk and are referred for treatment by Department of Corrections’ institutions and the Division of Probation and Parole via the designated referral form and protocol, as well as individuals referred from federal correctional institutions; (G) Individuals who are applying for or receiving Temporary Assistance for Needy Families (TANF) and are referred for treatment by the Department of Social Services, Family Support Division, via the designated electronic referral process and protocol. 1. Women who are pregnant shall receive immediate admission. 2. High-risk referrals from correctional institutions and probation and parole shall be assessed and admitted within five (5) working days of initial contact or scheduled release date, including weekends and holidays. 3. If the OTP is unable to assess and admit an individual who uses intravenous drugs within forty-eight (48) hours of receiving such a request, interim services shall be available in accordance with department contract requirements; (H) Interim treatment, as defined in section (17) of this rule, shall be available for individuals who are eligible for treatment but cannot be immediately admitted to the OTP where services are being sought or through documented agreement with another OTP; and (I) Individuals seeking treatment who are participants in the MO HealthNet program and do not meet priority population criteria shall be given an appointment in a timely manner and shall not be placed on a wait list. (7) Admission Protocol. Prior to admission, staff shall verify and document the individual seeking services is not currently enrolled in another opioid treatment program utilizing a central registry, if available, or other client enrollment/admission database, such as the department’s Customer Information, Management, Outcomes, and Reporting (CIMOR) system, for verification purposes. (A) An individual currently enrolled in an OTP shall not be permitted to obtain treatment in any other OTP except in exceptional circumstances. 1. If the medical director or program physician of the OTP where the individual is currently enrolled determines exceptional circumstances exist, the individual may be granted permission to seek treatment at another OTP. Justification for the exceptional circumstances must be included in the individual record at both program locations. (B) Upon admission, an initial medical examination shall be completed by an appropriately licensed practitioner for each individual. The initial examination shall ensure the individual meets admission criteria and there are no contraindications to treatment with MOUD. A full history and examination to determine the individual’s broader health status, including lab testing, may be required as determined by an appropriately licensed practitioner. 1. If the licensed practitioner is not an OTP practitioner, the screening examination must be completed no more than seven (7) days prior to OTP admission. When the examination is performed outside of the OTP, the written results and narrative of the examination, as well as available lab testing results, must be transmitted to the OTP and verified by an OTP practitioner, consistent with applicable privacy laws. 2. A full in-person physical examination, including the results of serology and other tests that are considered to be clinically appropriate, must be completed within fourteen (14) calendar days following an individual’s admission to the OTP. The full exam can be completed by a non-OTP practitioner if the exam is verified by a licensed OTP practitioner as being true and accurate and transmitted in accordance with applicable privacy laws. (C) Serology and other testing, as deemed medically appropriate by the licensed OTP, shall not be drawn more than thirty (30) days prior to admission to the OTP and may form part of the full history and examination. (D) The screening and full examination may be completed via telehealth if a practitioner or primary care provider determines an adequate evaluation can be accomplished for individuals being admitted to the OTP for use of buprenorphine or methadone. 1. When using telehealth, the following shall apply: A. When evaluating patients for treatment with Schedule II medications (such as methadone), audio-visual telehealth platforms must be used, except when not available to the patient. When not available, it is acceptable to use audio-only devices, but only when the patient is in the presence of a licensed practitioner who is registered to prescribe (including dispense) controlled medications. The OTP practitioner shall review the examination results and order treatment medications as indicated. (E) In evaluating patients for treatment with Schedule III medications (such as buprenorphine) or medications not classified as a controlled medication (such as naltrexone), audio-visual or audio only platforms may be used. The OTP practitioner shall review the examination results and order treatment medications as indicated. 1. An individual’s refusal to undergo lab testing for cooccurring physical health conditions shall not preclude them from access to treatment, provided such refusal does not have potential to negatively impact treatment with medications. 2. Women should have a pregnancy test as deemed clinically appropriate. 3. Serology testing and other testing as deemed medically appropriate by the licensed OTP practitioner based on the screening or full history and examination, drawn not more than thirty (30) days prior to admission to the OTP, may form part of the full history and examination. (8) Assessments. (A) The screening and full examination may be completed via telehealth for those patients being admitted for treatment at the OTP with either buprenorphine or methadone, if a practitioner or primary care provider determines that an adequate evaluation of the patient can be accomplished via telehealth. (B) When using telehealth, the following caveats apply: 1. In evaluating patients for treatment with Schedule II medications (such as methadone), audio-visual telehealth platforms must be used, except when not available to the patient. When not available, it is acceptable to use audio-only devices, but only when the patient is in the presence of a licensed practitioner who is registered to prescribe (including dispense) controlled medications. The OTP practitioner shall review the examination results and order treatment medications as indicated; 2. In evaluating patients for treatment with Schedule III medications (such as buprenorphine) or medications not classified as a controlled medication (such as naltrexone), audio-visual or audio only platforms may be used. The OTP practitioner shall review the examination results and order treatment medications as indicated; 3. Screening shall determine the risk of undiagnosed conditions such as hepatitis C, HIV, sexually transmitted infections, cardiopulmonary disease, and sleep apnea to determine if further diagnostic testing such as laboratory analysis, a cardiogram, or others are needed; 4. Positive screening results or disease risks should have a care coordination plan that is seen through to completion, regardless of whether this is accomplished via services provided directly by the OTP or through referral to another provider; and 5. A complete medical history, physical examination, and laboratory testing shall not be required for an individual who has had such medical evaluation within the prior thirty (30) days, or a physical examination completed no later than five (5) days after admission. The program shall have documentation of the medical evaluation and any significant findings in the individual record. Physical evaluations shall be completed no less than once per year. (9) Pregnant and Postpartum Women. Written policies and procedures shall be maintained and implemented to address the needs of women who are pregnant and postpartum. Prenatal care and other gender-specific services for women who are pregnant must be provided by the OTP or by referral to an appropriate healthcare provider. (A) For pregnant women who are receiving methadone or buprenorphine, the program shall have written policies and procedures in place to ensure— 1. The initial dose of medication for a newly admitted woman who is pregnant, and the subsequent induction and dosing strategy, reflect the same effective dosing protocols used for all other individuals; 2. The methadone dose is carefully monitored, especially during the third trimester when pregnancy induces changes such as the rate at which methadone is metabolized or eliminated from the system, potentially necessitating either an increased or a split dose; and 3. Women who become pregnant during treatment are maintained at pre-pregnancy dosage, if effective, and are managed with the same dosing principles used with women who are not pregnant. (B) Withdrawal management after pregnancy shall occur as clinically indicated and documented, or is requested by the individual. (C) When a planned discharge occurs, OTP staff shall document the contact information of the physician or other authorized healthcare professional to whom the individual has been referred, including the reason for discharge. (D) Mothers shall be educated about neonatal abstinence syndrome, its symptoms, potential effects on the infant, and need for treatment if it occurs. (10) Safety and Health. The program shall implement written policies, procedures, and practices which ensure access to services and address the safety and health of individuals served. The provider shall— (A) Ensure continued opioid treatment for individuals in the event of an emergency, pandemic, or natural disaster by cooperating with other OTPs, including those in surrounding states, to develop and maintain medication dosing arrangements; (B) Utilize a central registry, if available, or other individual enrollment/admission system such as the department’s CIMOR system, to coordinate services; (C) Ensure treatment to persons regardless of serostatus, HIVrelated conditions, tuberculosis (TB), or hepatitis C; (D) Provide information and education to individuals on prevention and transmission of HIV-related conditions; (E) Provide or arrange HIV testing and pre- and post-test counseling for individuals; (F) Provide or arrange testing for TB, hepatitis C, and sexually transmitted infections upon admission and at least annually thereafter; (G) Provide medical evaluations to individuals upon admission and at least annually thereafter, including cardiac risk assessment; (H) Utilize infection control procedures in accordance with federal, state, and local regulations; and (I) Arrange medical care for women during pregnancy, if necessary, and document the arrangements made and action taken by the individual. (11) Staff Training. Each person engaged in the treatment of OUD must have sufficient education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. All direct service staff and medical staff shall complete four (4) clock hours of training relevant to service delivery in an opioid treatment setting during a two- (2-) year period. This training applies to the required thirtysix (36) clock hours of training during a two- (2-) year period specified in 9 CSR 10-7.110(2)(F)1. and fifty (50) clock hours of training annually specified in 9 CSR 30-3.155(4)(H)1.-4. (12) Testing and Screening for Drug Use. The program shall use drug screenings as a clinical tool for purposes such as diagnosis and treatment planning. (A) Each individual shall have an initial toxicology test as part of the admission process. At a minimum, admission samples shall be analyzed for opiates, methadone, marijuana, cocaine, barbiturates, benzodiazepines, buprenorphine, amphetamines, fentanyl, and alcohol. (B) If there is a history of misuse of prescription opioid analgesics, an expanded toxicology panel that includes these opioids shall be administered. Additional testing shall be based on individual needs and local drug use patterns and trends. (C) Random drug testing of each individual in treatment shall be conducted at least eight (8) times during a twelve- (12-) month period, allowing for extenuating circumstances on behalf of the individual receiving services. (13) Unsupervised Approved Use (Take-Home) of Medication. The medical director shall ensure policies and procedures for approval of take-home methadone do not create barriers to individuals in treatment. The dispensing restrictions set forth in this section of this rule do not apply to buprenorphine and buprenorphine products. (A) Any individual in comprehensive treatment may receive individualized take-home doses as ordered for days that the clinic is closed for business, including one (1) weekend day (e.g., Sunday) and state and federal holidays, no matter the length of time in treatment. (B) Decisions on dispensing MOUD to individuals for unsupervised use, beyond that set forth in this rule, shall be determined by the medical director or appropriately licensed medical practitioner. In determining which individuals may be approved for unsupervised use, the medical director shall consider, among other pertinent factors that indicate that the therapeutic benefits of unsupervised doses outweigh the risks, the following criteria: 1. Absence of recent misuse of drugs (opioid or nonnarcotic), including alcohol, other physical or behavioral health conditions that increase the risk of individual harm as it relates to the potential for overdose, or the ability to function safely; 2. Regularity of attendance for supervised medication administration; 3. Absence of serious behavioral problems that endanger the patient, the public, or others; 4. Absence of known recent involvement in the legal involved system, such as drug dealing; 5. Assurance that take-home medication can be safely transported and stored; and 6. Any other criteria that the medical director or medical practitioner considers relevant to the individual’s safety and the public’s health. (C) Determinations for unsupervised use of methadone and the basis for such determinations shall be documented in the individual record. (D) Take-home doses dispensed to individuals shall be subject to the following: 1. During the first fourteen (14) days of treatment, the takehome supply is limited to seven (7) days; 2. From fifteen (15) days of treatment, the take-home supply is limited to fourteen (14) days. In the second ninety (90) days of treatment, the take-home supply is limited to two (2) doses per week; and 3. From thirty-one (31) days of treatment, the take-home supply provided to an individual is not to exceed twenty-eight (28) days. (E) It remains within the OTP practitioner’s discretion to determine the number of take-home doses, but this determination must be based on the criteria listed in subsection (13)(B) of this rule. (F) OTPs must implement written procedures to identify theft or diversion of take-home medications, including labeling containers with the OTP’s name, address, and telephone number. Programs must also ensure take-home supplies are packaged in a manner designed to reduce the risk of accidental ingestion, including use of child-proof containers. (G) Program staff shall educate individuals about safe transportation and storage of methadone, as well as emergency procedures in case of accidental ingestion. (H) Individuals approved for take-home doses of methadone must have a lock box for safe transportation and home storage. (I) OTPs shall implement written policies and procedures that address the responsibilities of individuals who are approved for take-home doses of methadone, including methods to assure appropriate use and storage of the medication. (J) Staff shall regularly monitor each individual’s use of takehome medication to ensure security of the medication and prevent diversion. When determined necessary, the medical director and staff may review an individual’s unsupervised use and may deny or rescind take-home privileges. Such action shall be documented in the individual record, including the rationale for denial or rescission of unsupervised use. (K) The time in treatment requirements outlined in paragraphs (13)(D)1. to 3. of this rule are minimum reference points after which an individual may be considered for takehome medication privileges. The time references do not mean an individual in treatment for a particular time has a specific right for approval of take-home medication. (L) Any deviation from the regulations for unsupervised use of methadone as specified in this rule requires prior approval from the state opioid treatment authority (SOTA), or designee, and/or SAMHSA. 1. The Exception Requests and Record of Justification form SMA-168 must be submitted to the SOTA/designee and/or SAMHSA as specified in section (25) of this rule. Justification for an exception may include, but is not limited to, transportation hardships, employment, vacation, medical or family emergencies, or other unexpected circumstances. (14) Guest Medication. Individuals who travel, but do not meet the criteria for take-home medication as specified in section (13) of this rule, should be considered for guest medication in accordance with the 2020 Guidelines for Guest Medications, hereby incorporated by reference and made a part of this rule, as published by the American Association for the Treatment of Opioid Dependence, 225 Varick St., Suite 402, New York, NY 10014, (212) 566-5555. This rule does not incorporate any subsequent amendments or additions to this publication. (A) Guest medication provides a mechanism for individuals to travel from a home program for business, pleasure, or family emergencies. It also provides an option for individuals who need to travel for a period of time that exceeds the amount of eligible take-home doses to do so within regulatory requirements. (B) Individuals shall be on a stable dose of methadone and not be scheduled for a dose increase or decrease during guest medication. (C) Individuals approved for guest medication must be medically and psychiatrically stable. (15) Continuity of Care. The program shall implement written policies and procedures to address continuity of care for individuals who are unable to participate in regularly scheduled visits for observed ingestion of medication due to illness, pregnancy, participation in residential treatment, incarceration, lack of transportation, or other situations. (A) A chain-of-custody process shall be implemented to document the transportation, delivery, administration, and observation of medication when an individual is unable to report to the program as required. (16) Diversion Control. OTPs shall maintain and implement a written diversion control plan as part of its performance improvement process. The plan shall contain specific measures to reduce the possibility of diversion of controlled substances from legitimate treatment use. Medical and administrative staff of the program shall be assigned to implement the diversion control measures and functions described in the diversion control plan. (17) Interim Treatment. The program sponsor of an OTP may place an individual who is eligible for admission to comprehensive treatment into interim treatment, if the individual cannot be placed in an OTP within a reasonable geographic area within fourteen (14) days of the individual’s seeking admission to treatment. (A) An initial and at least two (2) other drug screens shall be obtained from an individual during the maximum of one hundred eighty (180) days permitted for interim treatment. (B) By day one hundred twenty (120), a plan for continuing treatment beyond one hundred eighty (180) days must be created and documented in the individual’s clinical record. (C) The OTP shall maintain and implement written policies and procedures for transferring individuals from interim to comprehensive treatment. 1. The transfer criteria shall include, at a minimum, a preference for admitting women who are pregnant into interim treatment and criteria for transferring individuals from interim to comprehensive treatment. (D) Interim treatment shall be provided in a manner consistent with all applicable federal and state laws, including sections 1923, 1927(a), and 1976 of the Public Health Service Act (21 U.S.C. 300x-23, 300x-27(a), and 300y-11). (E) Individuals enrolled in interim treatment shall not be discharged without the approval of an OTP practitioner, who shall consider ongoing and individual treatment needs, which are to be documented in the clinical record, while awaiting transfer to a comprehensive treatment program. (F) The program shall notify the SOTA when an individual begins interim treatment, when the individual leaves interim treatment, and before the date of transfer to comprehensive treatment, documenting all notifications in the individual record. (G) SAMHSA may revoke the interim authorization for a program that fails to comply with the provisions of this section of this rule. (H) SAMHSA will consider revoking the interim treatment authorization of a program if the state in which the program operates is not in compliance with the provisions of 42 CFR section 8.11(g). (I) All requirements for comprehensive treatment apply to interim treatment with the following exceptions: 1. The opioid agonist treatment medication is required to be administered daily under observation; 2. An initial treatment plan and periodic treatment plan reviews are not required; 3. A primary counselor is not required to be assigned to the individual but crisis services, including shelter support, should be available; 4. Interim treatment shall not be provided for longer than one hundred eighty (180) days in any twelve- (12-) month period; and 5. The rehabilitative, educational, and other counseling services specified in section (4) of this rule are not required to be provided to the individual. (18) Medically Supervised Withdrawal. The program shall maintain and implement written policies and procedures that are designed to ensure that those patients who choose to taper from MOUD are provided the opportunity to do so with informed consent and at a mutually agreed-upon rate that minimizes taper-related risks. Medically supervised withdrawal may be voluntary or involuntary, as specified in sections (19) and (21) of this rule. (A) The individual’s treatment plan shall include a strategy to transition to another form of medication, if needed. Review of the risks and benefits of withdrawal shall be provided, and informed consent shall be obtained from individuals who voluntarily choose this treatment option. Such consent must be documented in the clinical record by the treating practitioner. (B) Individuals shall be educated about the risks of a recurrence of symptoms and potential for fatal overdose following withdrawal, and be offered relapse prevention services that includes counseling, naloxone, and opioid antagonist therapy. (C) OTPs shall offer a variety of supportive options as part of the transition from opioid agonist therapy, such as increased counseling sessions prior to discharge, and individuals shall be encouraged to attend a twelve- (12-) step or other mutualhelp program sensitive to the needs of individuals receiving treatment with medication. (19) Voluntary Medically Supervised Withdrawal. Voluntary medically supervised withdrawal may be initiated by the individuals served or the program physician in collaboration with the individual as part of individualized treatment planning. (A) As deemed clinically appropriate, women shall have a pregnancy test and the results reviewed prior to initiation of medically supervised withdrawal. (B) For women who are pregnant, the physician shall not initiate withdrawal before fourteen (14) weeks or after thirtytwo (32) weeks of pregnancy. (C) If an individual experiences intolerable withdrawal symptoms or actual or potential return to use, the physician shall consider stopping the withdrawal process and restoring the individual to a previously effective dose. In collaboration with the individual served, the physician shall determine if an additional period of maintenance is necessary before further medically supervised withdrawal is attempted. (D) Regardless of whether medically supervised withdrawal is conducted with or against medical advice (AMA), careful review of the risks and benefits of withdrawal from treatment must be provided to the individual and informed written consent obtained from those who choose to initiate medically supervised withdrawal. (20) Withdrawal Against Medical Advice (AMA). Individuals who request voluntary medically supervised withdrawal from medication treatment AMA of the physician or program staff may receive it. Individuals have the right to leave treatment when they choose to do so. (A) The same services that are available to individuals engaged in voluntary medically supervised withdrawal shall be offered to individuals choosing medically supervised withdrawal AMA. (B) The program must fully document the issue(s) that caused the individual to seek discharge, steps taken to avoid discharge, and the circumstances of readmission, as applicable. (C) In the case of a woman who is pregnant, the program must keep the physician or agency providing prenatal care informed, consistent with the privacy standards of 42 CFR section 2. (21) Involuntary Withdrawal from Treatment (Administrative Withdrawal). Individuals shall be retained in treatment for as long as they can benefit from it and express a desire to continue treatment. Administrative withdrawal is typically involuntary and shall be used only when all other therapeutic options have been exhausted by program staff. OTPs may refer or transfer individuals to a suitable alternative treatment program, as clinically indicated. (A) Missing scheduled appointments and/or continued drug use shall not be the sole reason for initiating involuntary withdrawal for an individual being served. (B) If involuntary withdrawal is initiated for an individual, the program shall follow the criteria included in the December 2024, Federal Guidelines for Opioid Treatment Programs, incorporated by reference and made a part of this rule as published by SAMHSA, Center for Substance Abuse Treatment, 1 Choke Cherry Rd., Rockville, MD 20857, (877) 726-4727, publication number PEP24-02-011. This rule does not incorporate any subsequent amendments or additions to this publication. (22) Medication Storage and Security. The program shall ensure the security of its medication supply and shall account for all medications kept on site at all times. (A) The program shall meet the requirements of the DEA and BNDD. (B) The program shall maintain an acceptable security system, and the system shall be checked on a quarterly basis to ensure continued safe operation. (C) The program shall physically separate the narcotic storage and dispensing area from other parts of the facility used by individuals. (D) The program shall implement written policies and procedures to ensure positive identification of all individuals before any medication is administered. Verification shall include a minimum of two (2) forms of identification. (E) The program shall implement written policies and procedures for recording each individual’s medication intake and maintaining a daily medication inventory. (23) Medication Units. Certified OTPs may establish medication units that are authorized to dispense MOUD. Services provided at the medication unit must comply with 42 CFR section 8.2. (A) Prior to establishing a medication unit, the OTP must notify and receive prior approval from the SOTA/designee and SAMHSA by submitting form SMA-162. The required documents include, but are not limited to— 1. A description of how the medication unit will receive its medication supply; 2. An affirmative statement that the medication unit is limited to administering and dispensing the narcotic treatment drug and collecting samples for drug testing or analysis; 3. An affirmative statement that the program sponsor agrees to retain responsibility for individual treatment and care; 4. A diagram and description of the facility to be used as a medication unit; 5. Total number of individuals to be served by the primary OTP and medication unit; 6. Total number of individuals that will be served only at the medication unit; 7. A justification for the need to establish a medication unit; and 8. The name and address of any other active medication unit(s) attached to the primary OTP. (B) A DEA inspection and approval must be obtained prior to opening a medication unit. A medication unit must have a separate and unique DEA registration. (C) The OTP must comply with the provisions of 21 CFR part 1300 prior to establishing a medication unit. (D) Medication units are not required to be free-standing entities and may be located at a hospital or community pharmacy, for example. (E) The certified OTP shall be responsible for all operations of an approved medication unit. (24) Mobile Units. A mobile unit, for the purpose of dispensing opioid agonist treatment medications to individuals for observed ingestion, may be established if approval is granted by the DEA allowing such units to be considered a coincidental activity of the registered OTP. OTPs shall follow all federal, state, and local regulations regarding the operation of a mobile unit. (25) Exception Requests and Records of Justification. Any deviation from these regulations requires prior approval from the SOTA/designee and/or SAMHSA. Requests must be submitted on the Exception Request and Record of Justification form (SMA-168) electronically. (A) OTPs shall follow department requirements for submitting form SMA-168 to the SOTA/designee and/or SAMHSA. Failure to submit the completed form and obtain prior approval from the SOTA/designee and/or SAMHSA constitutes a regulatory violation which may jeopardize the OTP’s accreditation and certification status. (B) SAMHSA and the SOTA/designee must be notified of any change to the OTP sponsor or medical director within three (3) weeks of the change by submitting SAMHSA form SMA-162 in accordance with established procedures. AUTHORITY: sections 630.655 and 631.102, RSMo 2016.* This rule originally filed as 9 CSR 30-3.610. Original rule filed May 13, 1983, effective Sept. 13, 1983. Rescinded and readopted: Filed May 3, 1994, effective Nov. 30, 1994. Amended: Filed July 29, 1997, effective Jan. 30, 1998. Moved to 9 CSR 30-3.132 and amended: Filed Feb. 28, 2001, effective Oct. 30, 2001. Amended: Filed Oct. 15, 2001, effective April 30, 2002. Amended: Filed March 8, 2002, effective Sept. 30, 2002. Amended: Filed July 1, 2003, effective Dec. 30, 2003. Emergency amendment filed Nov. 8, 2004, effective Nov. 18, 2004, expired May 16, 2004. Amended: Filed Nov. 8, 2004, effective April 30, 2005. Amended: Filed Feb. 1, 2005, effective July 30, 2005. Rescinded and readopted: Filed May 28, 2021, effective Dec. 30, 2021. Amended: Filed Aug. 19, 2025, effective March 30, 2026. *Original authority: 630.655, RSMo 1980, and 631.102, RSMo 1997.